FDA Approves BioXcel’s Agitation Drug Igalmi
BioXcel Therapeutics has received FDA clearance for its first drug, Igalmi, as a treatment for agitation in persons with Schizophrenia or Bipolar Disorder. Igalmi (dexmedetomidine) is the first drug approved for this application that comes in the form of a tablet that dissolves beneath the tongue, and it is the first novel treatment for agitation in patients with psychosis in nearly a decade. It's a significant milestone for the Connecticut biotech, but it's only the beginning of its aspirations for Igalmi, which it hopes to expand into additional settings such as agitation in Alzheimer's disease and as an add-on therapy...